The disclosure is directed to a system, device and methods for the treatment of genital tract infection.
Genital tract infection is a common and significant health problem for both women and men. Genital tract infection typically falls into one of three categories: endogenous infection, iatrogenic infection, and sexually transmitted infection (STI). Endogenous infection includes bacterial vaginosis and candidiasis, which result from an overgrowth of organisms that are normally present in the vagina. Despite known treatments for endogenous infection, endogenous infections are problematic because they have a high recurrence rate.
Iatrogenic infections represent another type of genital tract infection. Iatrogenic infection occurs when the infectious agent (a bacterium or other micro-organism) is introduced into the reproductive tract through various routes such as menstrual regulation, induced abortion, IUD insertion and/or parturition. Another type of genital tract infection is STI caused by microorganisms that are transmitted through sexual activity with an infected partner. Among the STIs there are several serious diseases such as HIV, Chlamydia trachomatis, human papillomavirus infection with cancerous and non-cancerous epithelial transformation (condyloma and cervical cancer), syphilis and gonorrhea. STIs can affect both men and women, and transmission from infected mother to child during pregnancy is also known.
Bacterial vaginosis (BV) is a frequent endogenous infection and also one of the most common medical conditions of the female genital tract. BV is linked to increased complication in pregnancy, poor birth outcomes including prematurity and systemic infection of the mother and newborn, and may be involved in the pathogenesis of pelvic inflammatory disease and women's risk of acquiring HIV and other STIs. Many questions remain about the etiology of BV, which complicates the management of recurrent infections.
BV is an overgrowth of anaerobic bacteria and a lack of normal Lactobacilli flora, which results in the imbalance of normal vaginal flora. During pregnancy BV is associated with poor perinatal outcome and a cause of preterm birth. Identification and treatment of BV may reduce the risk of such consequences.
Lactic acid, by way of release from an intravaginal delivery device (IDD), is a known treatment for BV. This treatment delivers lactic acid so as to mimic the natural acidic pH of the human vagina. Unfortunately, women who are susceptible to BV often experience frequent relapse and remissions of the condition. The art recognizes the high rate of recurrent BV even after successful episodic treatment.
Treatment of BV with lactic acid is difficult because effective BV treatment requires delivery of not only (i) a sustained amount of lactic acid but also (ii) a large amount of lactic acid into the vaginal cavity. Consequently, episodic treatment of BV is typically unsuccessful over the long term. Conventional IDDs are lacking because a typical IDD cannot keep pace with the natural rate of loss of lactic acid via diffusion through the vaginal epithelium. In particular, conventional IDDs cannot replenish lactic acid to the vaginal lumen at a rate fast enough and for long enough duration to keep pace with this transepithelial flux.
The art recognizes the need for a genital tract treatment regime that can provide both (i) a sustained amount and (ii) a large amount of a therapeutic agent to the genital tract over a long period of time. A need further exists for an intravaginal treatment of BV that can provide a sustained amount and a large amount of lactic acid for a greater time duration than is possible with a conventional IDD alone.